MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported a gradual loss of therapy on the left side of their body.It was stated that they were hospitalized because they thought their implantable neurostimulator (ins) was low and needed changing out.The patient met with the nurse practitioner about 2-3 weeks prior to date notified who told them the ins was getting low and needed to be replaced, so the settings were reduced to make the "rough patches" easier until they had the replacement.On the day prior to date notified the patient went to the er because they were "curling up so bad." specifically, their tongue, toes, back, and fingers all curl up due to their generalize d dystonia.The patient is currently on morphine to help control the pain and prevent the reported curling.The implant was checked with the patient programmer (pp) which showed stimulation on, and they are seeing the ins battery voltage change from 2.69v-2.74v, with it currently at 2.71v.It was confirmed the ins is left on at all times, and the husband of the patient reported that a nurse did check the device and indicated that it is fine and there is nothing wrong with it.The patient's indication for implant is dystonia and movement disorders.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6276951
• MDR Text Key: 65722388
• Report Number: 3004209178-2017-01695
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: 01/03/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR